510(k) K261456
- Device
- Ruthinium Disc
- Applicant
- Dental Manufacturing S.p.A.
- 510(k) number
- K261456
- Product code
- POW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-05
- Date received
- 2026-05-01
- Regulation
- 872.3770
- Classification name
- Crown And Bridge, Long-Term Temporary, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Barbara Piazza
- Address
- Via Cà Mignola Nuova 1699 Badia Polesine IT 45021 45021
FDA Registration Numbers#
- 3005904906
- 8044164
- 8010908
- 3007210751
- 3008912871
- 3009482106
- 3010664129
- 8031058
- 2023950
- 3030515618
- 3005942449
Source Documents#
Other 510(k) Records For Product Code POW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231591 | V-Print c&b temp | Voco GmbH | 2023-07-31 |